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Business EconomyPosted at: Nov 22 2018 4:12PM


Zydus receives approvals from the USFDA for Atorvastatin calcium tablets

Mumbai, Nov 22 (UNI) Pharma Major, Zydus Cadila has received
the final approval from the USFDA to market Atorvastatin
Calcium Tablets in the strengths of 10 mg, 20 mg, 40 mg and
80 mg (US RLD - Lipitor).
It will be manufactured at the group's formulations
manufacturing facility at Moraiya, Ahmedabad, company said
in a filing with BSE.
Atorvastatin is used along with a proper diet to help lower
"bad" cholesterol and fats (such as LDL, triglycerides) and
raise "good" cholesterol (HDL) in the blood. It belongs to a
group of drugs known as "statins." It works by reducing the
amount of cholesterol made by the liver. Lowering "bad"
cholesterol and triglycerides and raising ?good" cholesterol
decreases the risk of heart disease and helps prevent
strokes and heart attacks.
The group also received a tentative approval for Dimethyl
Fumarate Delayed-Release Capsules, 120 mg and 240 mg (US RLD
- TECFIDERA capsules).
It will be manufactured at the group's formulations
manufacturing facility at SEZ, Ahmedabad. Dimethyl Fumarate
is indicated for the treatment ofpatients with relapsing
forms of multiple sclerosis.
The group now has 233 approvals and has so far filed over
340 ANDAs since the commencement of the filing process in FY
2003-04.
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